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Scancell to collaborate with BioNTech

Scancell to collaborate with BioNTech to investigate T cell receptor based therapeutics for the treatment of cancer 

Agreement expands potential therapeutic utility of Moditope® to adoptive T cell therapy 

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that it has entered into a research collaboration with BioNTech for the potential development of innovative, T cell receptor based therapeutics for the treatment of cancer. This research collaboration combines Scancell’s Moditope® immunotherapy platform and BioNTech’s platform technology for high-throughput cloning and characterisation of naturally selected T cell receptors. 

Moditope® represents a completely new class of potent and selective immunotherapy agents which could have a profound effect on the way that cancer immunotherapies are developed. It acts by stimulating the production of CD4+ T cells using citrullinated tumour-associated peptide epitopes which overcome self-tolerance and destroy tumour cells. The technology overcomes the immune suppression induced by tumours themselves without the need for checkpoint blockade inhibitors, thereby allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system.

Under the terms of the agreement, Scancell and BioNTech will enter into an initial research collaboration to discover and characterise T cell receptors specific for citrullinated epitopes from vimentin and enolase. These epitopes form the basis of Scancell’s first Moditope® development candidate, Modi-1. Upon completion of these studies, BioNTech will have the exclusive option to enter into a licence agreement for the development of cell receptor based therapeutics that are specific to Modi-1 epitopes. 

Prof Lindy Durrant, Chief Scientific Officer of Scancell, commented: “We are delighted to be working with BioNTech, one of Europe’s new immuno-oncology power-houses, to investigate the development of targeted immunotherapies for the treatment of cancer. Pre-clinical data from our Moditope® platform has shown unprecedented anti-tumour effects can be delivered without the need for checkpoint inhibition. We believe that this, combined with BioNTech’s engineered T cells specific to Moditope® epitopes, could have great potential as a novel immunotherapy.”

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)    
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

 

About Scancell 

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone. 

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours with minimal toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

About BioNTech

BioNTech is Europe’s largest privately held biopharmaceutical company pioneering the development of individualized therapies for cancer and other diseases. The company combines all building blocks for individualized immunotherapy under one roof – from diagnostics and drug development to manufacturing. Its cutting-edge technologies range from individualized mRNA-based medicines through innovative chimeric antigen receptors and T-cell receptor-based products to novel checkpoint immunomodulators and small molecules. BioNTech’s approach is validated by five top-tier corporate partnerships with Genentech, Genmab, Eli Lilly and Company, Sanofi and Bayer Animal Health. Founded in 2008, BioNTech’s financial shareholders include the Struengmann Family Office as majority shareholder, MIG Fonds, Salvia, Redmile Group, Janus Henderson Investors, Invus, Fidelity Management & Research Company and several European family offices.

Results of October 2017 AGM

Results of AGM

Scancell Holdings Plc, (AIM:SCLP), the developer of novel immunotherapies for the treatment of cancer, announces that all resolutions proposed at the Annual General Meeting were duly passed.

For Further Information:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)    
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

 Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

 Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

 Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

 Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

Final Results for the year ended 30 April 2017

Landmark five year survival achieved in resected SCIB1 patients

Emerging pipeline of three products across five cancer

Scancell Holdings plc, (‘Group’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, announces results for the year ended 30 April 2017.

Read the full document here

Highlights

  • Strong survival data for patients with Stage III/IV malignant melanoma on SCIB1 Phase 1/2 clinical trial
    •  8 of 20 patients with resected disease remain alive, survival well beyond established norms
    •  Of the 16 resected patients who received a 2-4mg dose of SCIB1, seven patients have now survived for five years since starting treatment and only six patients have had recurrence of their disease, of whom, two have died
    •  Final Clinical Study Report completed in December 2016 which included safety, immunology and clinical data from patients with Stage III/IV melanoma up to 29 October 2015
  • Investigational New Drug (IND) application for SCIB1 Phase 2 checkpoint inhibitor combination study expected to be submitted in early 2018, with patient enrolment planned for 2018
  • Continued good progress in development of Modi-1, our lead product from the Moditope® platform
    • Ultra-efficient linked adjuvant identified that works at up to 100-fold lower doses than could be achieved previously
    • Aiming to file a Clinical Trial Application (CTA) in the UK for the planned Phase 1/2 clinical trial in breast cancer, ovarian cancer and sarcoma in 2018
    • Early feedback from the European Patent Office suggests that broad patent claims for the Moditope® platform may be allowable
  • Opening of new offices in San Diego to support the Company’s US growth plans, and in Oxford for its UK corporate and development activities
  • Loss for year of £3.5m (2016: loss £2.6m)
  • Group cash balance at 30 April 2017 was £2.7m (30 April 2016: £6.5m)

Post Period Highlights:

  • Raised £4.7m in a placing of new ordinary shares
    • Funds to be used to initiate the clinical development of Modi-1 and to continue to support the ImmunoBody® platform pipeline
  • Patent granted in Europe for Scancell’s DNA ImmunoBody® technology
    • Counterparts to this patent have already been granted in the US, Australia and Japan

Dr Richard Goodfellow, CEO of Scancell, said:

“We have made further significant progress during the course of the past year on the development of our ImmunoBody® and Moditope® platforms.  We continue to report strong survival data in patients with Stage III/IV melanoma from our SCIB1 Phase 1/2 clinical trial, with survival times now exceeding five years in resected patients.

Moditope® is also progressing well with the identification of a new linked adjuvant for the first Modi-1 clinical trial in the UK in patients with breast cancer, ovarian cancer and sarcoma which is expected to increase the potency of the product up to 100-fold. We are continuing to explore a number of funding options to ensure that we have the resources to progress these programmes through their next phase and the Board believes that this funding could be best achieved following the execution of one or more partnerships on the ImmunoBody® or Moditope® platforms, on which significant progress has been made since the year end.”

For Further Information:

Scancell Holdings Plc

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon & Co +44 (0) 20 7886 2500
Tom Salvesen (Corporate Broking)    
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

Continued progress on SCIB1 – eight patients reach 5 year survival milestone

Scancell Holdings plc

(“Scancell” or the “Company”)

Continued progress on SCIB1 – eight patients reach 5 year survival milestone

US IND on schedule for submission in 3Q17; New batch of SCIB1 for planned US CI combination study successfully manufactured 
Most resected Stage III and IV melanoma patients from the SCIB1 Phase 1/2 clinical trial remain alive and without disease recurrence
ImmunoBody patent approved in all major markets

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, today provides an update on SCIB1, the lead programme from the Company’s ImmunoBody® platform, and its future plans for a US clinical trial in malignant melanoma.

Dr Richard Goodfellow, CEO of Scancell, said: “We are pleased to report that most patients with resected disease enrolled in the SCIB1 clinical trial are still alive and without disease recurrence, including the majority of patients who were previously undergoing continuation treatment. As previously announced, our next study, which will be in the US, will assess the potential for an increase in response rate in patients with malignant melanoma when treated with SCIB1 and a checkpoint inhibitor. We remain on track to submit the IND for this study in 3Q17.

Dr Keith Flaherty, Director of the Termeer Center for Targeted Therapy at the Massachusetts General Hospital Cancer Center and Professor of Medicine at Harvard Medical School, commented: “Despite the plethora of combination regimens under evaluation in melanoma, we believe that the SCIB1 / Checkpoint Inhibitor combination represents a novel, rational and safe approach that offers considerable clinical potential in a disease that still has significant medical need.”

SCIB1 Survival Update

As of July 2017, SCIB1 continues to deliver strong survival data:

  • Overall, 18 of 20 stage III/IV melanoma patients with resected disease remain alive with survival well beyond the established norms † Of the 16 resected patients who received 2-4mg doses of SCIB1, only six patients have had recurrence of their disease and of whom, only two have died. The median observation time for this group of patients is now 4.75 years, with seven patients surviving for more than 5 years since starting treatment and only three having evidence of disease recurrence during that period. *
  • One patient with unresected disease has also survived for more than 5 years since starting treatment with SCIB1, despite disease progression.*
  • Two of four resected patients who received 8 mg doses of SCIB1 have experienced disease recurrence although none have died.* The median observation time for this group of patients is 28 months

*All patients who relapsed went on to receive additional therapies for their melanoma

† Recurrence-free survival at 3 years in 951 resected stage III patients was 46.5% on ipilimumab and 34.8% on placebo (Eggermont et al Lancet Oncol 2015 May;16 (5):522-30) versus 69% at 3 years in 16 resected stage III/IV patients treated with SCIB1.

SCIB1 drug product manufacture and US IND

The new batch of SCIB1 has been manufactured successfully and will be released for clinical use in 3Q17. Following the pre-IND meeting held with the FDA in February 2017, we remain on track to submit the IND for a Phase 2 SCIB1/CI combination study in 3Q17.

SCIB1 continuation treatment

Of the eight patients who were previously receiving long term continuation treatment until this was suspended in June 2016, three have experienced a recurrence of their melanoma. The other five patients remain disease-free. Following a review with our clinical investigators it has been decided not to continue the SCIB1 long term continuation treatment in the five remaining disease-free patients. These patients have received between six and 17 doses of SCIB1 prior to a dosing holiday of more than 15 months. The company believes that the effects of any further dosing would therefore be difficult to interpret and to justify to the regulatory authorities.

ImmunoBody patent

As previously reported, a patent for its DNA ImmunoBody® technology has now been granted in Europe. This patent will extend global coverage of Scancell’s intellectual property with counterparts already granted in the United States, Australia and Japan.

Investor Events

Proactive One2One Forum, 13 July 2017 – Dr Richard Goodfellow

The event will commence at 6.00pm at the Chesterfield Mayfair Hotel, 35 Charles Street, Mayfair. Attendance is free. Proactive Investors One2One Forums have rapidly gained global recognition for companies to present to an audience of astute high net worth investors, fund managers, private client brokers and analysts. See Proactive Investors website for more details: http://www.proactiveinvestors.co.uk/register/event_details/106

The Company will provide a corporate presentation and will provide an update on its immunotherapy platform technologies:

  • ImmunoBody® - Best-in-class DNA vaccine technology for use in combination with checkpoint inhibitors or as monotherapy for patients with resected disease
  • Moditope® - Novel immunotherapy that destroys tumours and extends survival without the need for checkpoint inhibition

For further information, please contact:

Dr John Chiplin, Executive Chairman Scancell Holdings Plc +1 858 900 2646
Dr Richard Goodfellow, CEO   +44 (0) 20 3727 1000
Freddy Crossley (Corporate Finance) Panmure Gordon  +44 (0) 20 7886 2500
Maisie Atkinson (Sales)   +44 (0) 20 7886 2905
Mo Noonan/Simon Conway FTI Consulting + 44 (0) 20 3727 1000

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms.

Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma.  Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects.  In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone.  Experimental data suggests that the high avidity T cells induced by ImmunoBody® vaccines increase expression of PDL-1 on the tumour cell surface, thereby making the tumours more sensitive to checkpoint inhibitor drugs.  Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody® induces a powerful memory response.  Such an effect has not been observed with checkpoint inhibitors.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity.  The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

 

DNA ImmunoBody® Patent Granted in Europe

Scancell Holdings plc, (‘Scancell’ or the ‘Company’) the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that a patent for its DNA ImmunoBody® technology has now been granted in Europe.
The European patent, number 2134357, granted by the European Patent Office, covers Scancell’s DNA ImmunoBody® platform technology and is key to the protection of the Company’s pipeline of ImmunoBody®vaccines, including lead candidates, SCIB1 and SCIB2.

On issuance, this patent will extend coverage of Scancell’s intellectual property into another important market for Scancell. Counterparts to this patent have already been granted in the United States, Australia and Japan.

The European patent covers the following countries: Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Sweden and Turkey.

Dr. Richard Goodfellow, Chief Executive Officer of Scancell, commented:
“The addition of this key European patent for DNA ImmunoBody® significantly bolsters our global intellectual property portfolio as we position the company for future growth.”

For Further Information:

Dr John Chiplin, Executive Chairman

Dr Richard Goodfellow, Joint CEO

Scancell Holdings Plc

+1 858 900 2646

+ 44 (0) 20 3727 1000

Freddy Crossley (Corporate Finance)

Tom Salvesen (Corporate Booking)

Panmure Gordon & Co

+44 (0) 20 7886 2500

+44 (0) 20 7886 2500

Mo Noonan/Simon Conway FTI Consulting

+ 44 (0) 20 3727 1000

 

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® an Moditope® technology platforms. Scancell’s first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma. Data from the Phase 1/2 clinical trial demonstrate that SCIB1, when used as monotherapy, has a marked effect on tumour load, produces a melanoma-specific immune response and highly encouraging survival trend without serious side effects. In patients with resected disease there is increasing evidence to suggest that SCIB1 may delay or prevent disease recurrence.

Scancell’s ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system: the helper cell system where inflammation is stimulated at the tumour site and the cytotoxic Tlymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Pre-clinical data on a combination of SCIB1 or SCIB2 and checkpoint inhibition (blockade of the PD-1 or CTLA-4 immune checkpoint pathways) have shown enhanced tumour destruction and significantly longer survival times than when either treatment was used alone. Experimental data suggests that the high avidity T cells induced by ImmunoBody® vaccines increase expression of PDL-1 on the tumour cell surface, thereby making the tumours more sensitive to checkpoint inhibitor drugs. Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody® induces a powerful memory response. Such an effect has not been observed with checkpoint inhibitors.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4+ T cells that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.